510(k) · Cleared
ClearedVasopress DVT System, Model VP500D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compression Therapy Concepts, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Nov 30, 2006 after a 156-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Nov 30, 2006
- Review
- 156 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK061814 Vasopress DVT System, Model VP500DCompression Therapy Concepts, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK090074 Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK101702 Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010
- Descendant · cites it directly · 0 of its ownK101330 Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot…Midwest Reprocessing Center, LLC · 2010
Most influential descendants
Showing 3 of 3 · See all- K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009 · cites it directly1descendant
- K101702Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010 · cites it directly0descendants
- K101330Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest…Midwest Reprocessing Center, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061814 | Vasopress DVT System, Model VP500D | Compression Therapy Concepts, Inc. | 2006 | — |
| +1 | K090074 | Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs | Hygia Health Services, Inc. | 2009 | — |
| +1 | K101702 | Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs | Midwest Reprocessing Center, LLC | 2010 | — |
| +1 | K101330 | Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs… | Midwest Reprocessing Center, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JOW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JOW device
- #1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K090074 (Hygia Health Services, Inc., 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOW
168in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOW
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOW
24in 2025
MAUDE reports naming product code JOW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 66 | 0 | 12 |
| 2008 | 4 | 112 | 7 | 36 |
| 2009 | 3 | 84 | 0 | 45 |
| 2010 | 18 | 71 | 2 | 66 |
| 2011 | 11 | 104 | 3 | 50 |
| 2012 | 13 | 63 | 2 | 100 |
| 2013 | 17 | 94 | 0 | 169 |
| 2014 | 16 | 91 | 0 | 93 |
| 2015 | 10 | 160 | 0 | 137 |
| 2016 | 9 | 121 | 0 | 150 |
| 2017 | 9 | 116 | 1 | 149 |
| 2018 | 11 | 136 | 0 | 114 |
| 2019 | 11 | 88 | 1 | 102 |
| 2020 | 14 | 158 | 0 | 50 |
| 2021 | 16 | 132 | 0 | 34 |
| 2022 | 7 | 80 | 0 | 27 |
| 2023 | 6 | 160 | 0 | 57 |
| 2024 | 8 | 197 | 0 | 30 |
| 2025 | 7 | 168 | 0 | 24 |
| 2026 | 6 | 252 | 0 | — |
What is it indicated for?
The VasoPress pump (VP500D) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061814: Vasopress DVT System, Model VP500D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061814
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026